510(k) Report

Devices descending from K171661

3 later devices reach Scopis Extended Instrument Set EM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202609Instrument Clamps ElectromagneticStryker Corporation20200—
+1K193118TGS Guidewire and updated Scopis SoftwareStryker Ent20201—
+2K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…Stryker Corporation202201